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Completed

NCT Number: NCT06748469

Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain

Brief Summary:

This study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. The PRF procedure will be applied to the dorsal root ganglion (DRG) under fluoroscopic guidance.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital Pain Medicine

Ankara, Turkey (Türkiye)

About this study

In this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. After identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. The tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. Once the RF cannula is properly positioned, an RF electrode will be inserted through the cannula and connected to the RF generator. The final position of the RF cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 V and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold.

In the short-duration PRF group, a PRF cycle will be applied at 42°C for 240 seconds, while in the long-duration group, it will be applied at 42°C for 480 seconds. Following the PRF application, epidural spread will be confirmed using contrast dye, after which 4 mL of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years

  • Pain severity NRS ≥ 4
  • Pain duration > 12 weeks Refractory to conservative treatments (physical therapy, medical treatments) Exclusion Criteria Malignancy-related pain Diagnosis of diabetes mellitus or polyneuropathy Back pain more severe than leg pain Conditions that impair follow-up (e.g., psychiatric disorders, dementia) Patients refusing the procedure

Treatment and study plan

The duration of the intervention will be 240 seconds

Procedure

Dorsal Root Ganglion pulsed radiofrequency 240sec

Dorsal Root Ganglion pulsed radiofrequency 480sec

Procedure

The duration of the intervention will be 480 seconds

Primary outcomes

  1. Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))

    Time frame: 1, 3, and 6 months

    Change in pain severity

Secondary outcomes

  1. Global perceived effect (GPE)

    Time frame: 1, 3, and 6 months

    Change in GPE scores according to the 7-point Likert scale (1=worst, 7=best) over time will be used to assess patient satisfaction and improvement

  2. Oswetry disability index (ODI)

    Time frame: 0, 1, 3, and 6 months

    Change in 10-item Oswestry disability index (ODI) questionnaire (range: 0-100; 0 = no disablility) over time will be used to assess physical function

  3. Patient satisfaction

    Time frame: 1, 3, and 6 months

    Change in Patient satisfaction (5-point Likert scale, 0= very disappointed, 5=very satisfied) over time will be used

  4. Change in analgesic use

    Time frame: 1, 3, and 6 months

    Change in analgesic use over time (0=same, 1=decreased, 2=increased)

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Analgesic Efficacy of Different Pulse Radiofrequency Treatment Durations in the Management of Lumbosacral Radicular Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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